Multicenter Parallel Phase II Trial of BI 2536 Administered as One Hour IV Infusion Every 3 Weeks in Defined Cohorts of Patients With Various Solid Tumors. A New Drug Screening Program of the EORTC Network of Core Institutions (NOCI)

Further document its safety profile in the treated patient population.

Describe the plasma concentration time-course following administration of a single administration of BI 2536 in patients with different tumor types using an appropriate population pharmacokinetic model.

OUTLINE: This is a multicenter study.

Patients receive BI 2536 IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Blood is collected periodically during study. Plasma samples are analyzed for pharmacokinetic studies by HPLC and tandem mass spectrometry.

After completion of study treatment, patients are followed every 3 months.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Tumor-specific criteria:

Head and neck cancer:

Histologically or cytologically proven squamous cell carcinoma of the head and neck (excluding nasopharyngeal primaries)

Patients presenting with new non-irradiated lesions in pre-irradiated field as target lesions are eligible

Recurrent or metastatic disease, no longer suitable for local therapy

Prior use of chemotherapy/chemoradiotherapy/EGFR inhibitors for the treatment of the primary disease/nonmetastatic disease is allowed

Other types of sarcoma (not listed as not eligible), if approved by the Study Coordinator (written or e-mail approval needed prior to registration)

Excluded are any of the following:

Embryonic rhabdomyosarcoma

Chondrosarcoma

Osteosarcoma

Ewing tumors/primitive neuroectodermal tumors

Gastrointestinal stromal tumor

Dermatofibrosarcoma protuberans

Inflammatory myofibroblastic sarcoma

Neuroblastoma

Malignant mesothelioma

Mixed mesodermal tumors of the uterus

Patients must have received no more than one combination or two single agents of chemotherapy regimen for advanced disease and treatment must have included an anthracycline if not medically contraindicated

Melanoma

Histologically proven metastatic malignant melanoma

Ocular melanomas are excluded

Patients must either not have received any prior chemotherapy for recurrent /metastatic disease or have received one line of chemotherapy pending LDH ≤ 2 times upper limit of normal (ULN)

One prior line of immunotherapy is allowed

General criteria:

Measurable disease, defined as unidimensionally measurable based on RECIST with a target lesion of at least 20 mm or 10 mm measured by spiral CT scan

Documented progressive disease proven by imaging prior to study entry (i.e., progression should be documented by 2 imaging scans performed within the past 6 months prior to registration showing progression according to RECIST)

No clinical evidence of brain metastases

PATIENT CHARACTERISTICS:

Male or female

Menopausal status not specified

ECOG performance status 0-2

ANC ≥ 1.5 x 10^9/L

Platelets ≥ 100 x 10^9/L

Hemoglobin ≥ 9 mg/dL

Serum creatinine ≤ to 175 μmol/L

Bilirubin ≤ 1.5 times ULN

AST/ALT ≤ 2.5 times ULN (5 times ULN with liver metastases)

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception during and for 12 months after completion of study treatment

Absence of any psychological, familial, sociological, or geographical factors that would potentially hamper compliance with the study protocol and follow-up schedule

No other previous or active malignancy for at least 5 years with the exception of cone-biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma

No concomitant intercurrent illnesses including, but not limited to, any of the following:

Ongoing or active infection

Symptomatic congestive heart failure

Unstable angina pectoris

Cardiac arrhythmia

Psychiatric illness or social situation that would limit compliance with trial requirement or that are considered relevant for the evaluation of the efficacy or safety of the trial drug

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

At least 4 weeks since administration of any prior systemic treatment for the current malignancy including treatment with chemotherapy, radiotherapy, immunotherapy, hormonal therapy, and treatment with monoclonal antibodies, or small molecule tyrosine kinase inhibitors and others

No treatment with any other investigational drug within the past four weeks or within less than four half-life times of the investigational drug before treatment with the trial drug (whatever is the longest period)

No major surgery within 4 weeks prior to the first treatment with the trial drug

Concurrent treatment with corticosteroids, including prednisone and bisphosphonates, is allowed as long as the treatment started before entry into the study and as long as the dose is stable for two weeks prior to enrollment in the present trial

Palliative radiotherapy may be given during the study for bone pain or for other reasons not due to progressive disease (e.g., bronchial obstruction, ulcerating skin lesions)

The irradiated area should be limited and should not involve more than 10% of the bone marrow

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00526149